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Cenerimod

Phase 3

Lupus Erythematosus, Systemic | Small molecule | Immunology |Viatris Inc.|Last Updated: May 6, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials3
Total Enrollment1,601
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06475742Long-term Safety and Tolerability of Cenerimod in Adults With Systemic Lupus ErythematosusPHASE3 ENROLLING BY_INVITATION 680Jul 30, 2024May 1, 2028May 6, 2026106 United States, Argentina +21
NCT05672576A Research Study to Evaluate the Efficacy and Safety of Cenerimod in Subjects Suffering From Systemic Lupus ErythematosusPHASE3 ACTIVE NOT_RECRUITING 451Jun 26, 2023May 1, 2027Apr 2, 2026147 United States, Chile +16
NCT05648500A Research Study to Evaluate the Effects of a New Oral Medicine Called Cenerimod in Adults With Systemic Lupus ErythematosusPHASE3 ACTIVE NOT_RECRUITING 470Dec 13, 2022May 1, 2027May 6, 2026198 United States, Argentina +15
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Study Endpoints
Primary Endpoints
Treatment-emergent adverse events
Day 1 (post dose) to a maximum of 3.5 years

Occurrence of treatment-emergent adverse events up to the final study visit (maximum 3 years of study treatment plus 6-month safety follow-up period).

Serious adverse events
Day 1 (post dose) to a maximum of 3.5 years

Occurrence of serious adverse events up to the final study visit (maximum 3 years of study treatment plus 6-month safety follow-up period).

Adverse events of special interest
Day 1 (post dose) to a maximum of 3.5 years

Occurrence of adverse events of special interest up to the final study visit (maximum 3 years of study treatment plus 6-month safety follow-up period). Adverse events of special interest include the anticipated risks of treatment with cenerimod, known class effects, and events that may be related to systemic lupus erythematosus comorbidities, i.e., adverse events related to: * Effects on heart rate and rhythm * Hypotension * Hypertension * Cardiovascular * Hepatobiliary disorders / liver enzyme abnormalities * Pulmonary * Eye disorders * Infections * Skin malignancies * Non-skin malignancies

Response on Systemic Lupus Erythematosus Responder Index 4 (SRI-4) at Month 12 compared to baseline
At Month 12 compared to Day 1 (pre-dose baseline)

Response on SRI-4 is defined as: * Reduction from baseline of at least 4 points in the modified Systemic Lupus Erythematosus Disease Activity Index-2000 score (mSLEDAI-2K \[SLEDAI-2K modified to exclude leukopenia, thus mSLEDAI-2K\]), and * No new British Isles Lupus Assessment Group-2004 (BILAG) A organ domain score and not more than one new BILAG B organ domain score compared to baseline, and * No worsening from baseline in subjects' lupus disease activity, where worsening is defined as an increase ≥ 0.30 points on a 3-point Physician's Global Assessment visual analog scale (PGA VAS), and * No violation of specified medication rules detailed in the core protocol.

Secondary Endpoints
Response on BILAG-based Composite Lupus Assessment (BICLA) at Month 12 compared to baseline
At Month 12 compared to Day 1 (pre-dose baseline)
Time to first confirmation of a 4-month sustained modified Systemic Lupus Erythematosus Disease Activity Index-2000 (mSLEDAI-2K) response
Day 1 (pre-dose baseline) to Month 12
Time to first confirmation of a 4-month sustained response in mucocutaneous manifestations (i.e., rash, alopecia, mucosal ulcers)
Day 1 (pre-dose baseline) to Month 12
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cenerimod 4 mgEXPERIMENTALParticipants will receive oral cenerimod once daily in addition to background systemic lupus erythematosus therapy, for at least 1 year and up to a maximum of 3 years.
PlaceboPLACEBO_COMPARATORParticipants will receive matching placebo once daily in addition to background SLE therapy.
Matching placeboPLACEBO_COMPARATORParticipants will receive matching placebo once daily in addition to background SLE therapy.
Interventions
NameTypeDescription
CenerimodDRUGFilm-coated tablets at a dose of 4 mg.
PlaceboDRUGMatching placebo will be supplied as identical film-coated tablets formulated with the same excipients but without the active ingredient, cenerimod.
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites106

Inclusion Criteria: 1. Signed and dated informed consent form prior to any study-mandated procedure. 2. Participants with a diagnosis of systemic lupus erythematosus who: * Completed the 12-month double-blind treatment period of either of the parent studies (ID-064A301, ID-064A302). * Did no...

Countries:United StatesArgentinaBrazilBulgariaChileColombiaCzechiaGeorgiaGermanyGreeceMexicoPeruPhilippinesPolandPortugalPuerto RicoRomaniaSerbiaSouth AfricaSouth KoreaSpainTaiwanThailandIndiaMalaysiaUkraineUnited KingdomFranceJapan
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06475742primaryCompletionDate: changed
LOWMay 26, 2026NCT05672576primaryCompletionDate: changed
MEDIUMMay 26, 2026NCT05648500Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWMay 24, 2026NCT05648500studyFirstPostDate: changed
LOWMay 24, 2026NCT06475742studyFirstPostDate: changed
LOWMay 24, 2026NCT05672576studyFirstPostDate: changed